Zimmer Persona Personalized Knee System

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Persona Personalized Knee System.

Pre-market Notification Details

Device IDK173417
510k NumberK173417
Device Name:Zimmer Persona Personalized Knee System
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Zimmer, Inc. P.O. Box 708 Warsaw,  IN  46581 -0708
ContactNicole Meredith
CorrespondentNicole Meredith
Zimmer, Inc. P.O. Box 708 Warsaw,  IN  46581 -0708
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-01
Decision Date2018-01-30
Summary:summary

NIH GUDID Devices

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